phenylpropanolamine and catastrophic stroke

"Two federal officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs - Advair®, Symbicort®, Serevent® and Foradil®." - Gardiner Harris, 12/05/08

1982 FDA report warns that phenylpropanolamine has "the ability to cause cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias."

Two years later a memo from the medical services department at Sandoz Pharmaceuticals, which made the phenylpropanolamine products Triaminic® and Tavist-D®, referred to phenylpropanolamine as "an agent known to cause hypertension and stroke," yet the pharmaceutical industry accelerated their marketing of phenylpropanolamine, winning FDA approval to sell prescription phenylpropanolamine products on an over-the-counter basis while introducing flavorful new formulas for young children.

The pharmaceutical industry consistently challenged any notion that phenylpropanolamine could be dangerous and dismissed evidence to the contrary.

Tracy Patton, at 37, and Tricia Newenham, at 15, had catastrophic strokes.

Only hours before the catastrophic strokes each victim had taken an over-the-counter medicine containing phenylpropanolamine the active ingredient in scores of popular nonprescription decongestants and diet aids.

1999 Landmark $5 million Yale University study sponsored by the pharmaceutical industry concludes the use of phenylpropanolamine is associated with an increased risk of catastrophic stroke.

Tracy Patton and Tricia Newenham, who had taken Triaminic® cold syrup, were among hundreds of phenylpropanolamine consumers who had catastrophic strokes.

The pharmaceutical industry launches a yearlong campaign to keep the results quiet and stall government regulation.

By the time the phenylpropanolamine is removed from over-the-counter medicine, 13 months and hundreds of strokes later, the companies have reformulated their brand names with little interruption in sales or cash flow.

The PHRMA market for phenylpropanolamine, estimated at $500 million to $1 billion anually, is saved and in the interim, Americans continue to purchase phenylpropanolamine products off the shelf assuming they are safe.

The pharmaceutical industry hoped to make it through the 2000 cold season without pulling phenylpropanolamine products.

November 2000 Two weeks after an FDA advisory panel concluded that phenylpropanolamine could be hazardous, an official with Bayer, which made Alka-Seltzer Plus® with phenylpropanolamine, drafted a proposed "phenylpropanolamine crisis action plan."

The crisis action plan's stated objectives: "Delay mandatory implementation of FDA recommendation. Blunt PR impact by highlighting as questionable study conclusions as they pertain to cough/cold products."

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